The Recall Desk
HighFDA (Devices)·Z-0471-2022·Announced 2022-01-19

Philips Azurion X-ray System recalled for startup and emergency stop failures

Philips recalls 10 Azurion interventional X-ray systems due to intermittent startup communication failures and emergency stop recovery issues that could prevent system restart and movement functionality.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall with no reported hospitalizations, injuries, or adverse events. The hazard involves potential loss of critical system functionality in a high-risk clinical setting, meeting the criteria for High severity as a risk-of-harm product without reported injury.

Plain-English summary

Philips North America LLC is recalling 10 Philips Azurion Interventional Fluoroscopic X-ray Systems due to two identified operational issues. The affected models are 722221, 722228, 722225, 722068, 722226, 722078, and 722224. One system is located in Washington state in the United States; nine are distributed worldwide in France, Germany, Japan, Poland, and the United Kingdom.

The recall addresses two issues: (1) the system may intermittently fail to establish communication with the control unit that manages stand movement during startup, preventing the system from starting normally; and (2) the warm restart following an emergency stop may not execute correctly, rendering movement functionality unavailable. These failures could compromise the device's operational capability during clinical procedures.

Affected customers have been notified. Healthcare facilities should contact Philips for guidance on the affected systems, including serial numbers and UDI codes specific to their equipment. No patient injuries or adverse events have been reported in connection with these issues.

The recalled product

Product
Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224
Manufacturer
Philips North America Llc
Category
Medical Device — Interventional Imaging Equipment
Hazard
  • startup-failure
  • communication-failure
  • emergency-stop-failure
  • movement-dysfunction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • 722228 Azurion 5 M20 3 (01)00884838099234(21)3
  • 722221 Azurion 3 M12 8 (01)00884838099203(21)8
  • 722225 Azurion 7 B12 16 (01)00884838099265(21)16
  • 722225 Azurion 7 B12 73 (01)00884838099265(21)73
  • 722226 Azurion 7 B20 42 (01)00884838099272(21)42
  • 722226 Azurion 7 B20 157 (01)00884838099272(21)157
  • 722224 Azurion 7 M20 293 (01)00884838099258(21)293
  • 722078 Azurion 7 M12 220 (01)00884838085251(21)220

Distribution

Distributed nationwide across the United States.

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